ENPATH
Received Jul 29, 2010 · Event occurred Jun 22, 2010
Report 2124215-2010-13083 · MDR key 1774769
Device
Product problems
- Failure to Capture
- High impedance
- Connection Problem
Patient
65 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED OUT OF RANGE PACING IMPEDANCES AND A LOSS OF CAPTURE WITH THRESHOLD TESTING ON THE RIGHT AND LEFT VENTRICULAR LEADS. SHOCK LEAD IMPEDANCES WERE WITHIN RANGE. THERE WAS INQUIRY OF A POSSIBLE SETSCREW ISSUE. TECHNICAL SERVICES DISCUSSED POSSIBILITIES AND TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
RESOLUTION WAS REQUESTED FROM THE FIELD HOWEVER, NOTHING FURTHER AS BEEN RECEIVED. A RETURN REQUEST WAS MADE SHOULD THE PRODUCTS BE EXPLANTED. INFORMATION SUGGEST THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative
IT WAS LATER REPORTED THAT DURING A REVISION PROCEDURE IT WAS DISCOVERED THAT ONE OF THE SETSCREWS HAD NOT BEEN SCREWED DOWN. ONCE BOTH SETSCREWS WERE SET IN THE HEADER OF PACE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD, THE IMPEDANCE WAS NORMAL AND THE SYSTEM WORKED APPROPRIATELY.
Description of Event or Problem
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